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A Phase IB Study of LEE011 and Exemestane with and without Everolimus in Women with Locally Advanced or Metastatic Breast Cancer

Full Title

A Phase Ib/II Trial of LEE011 in Combination with Everolimus (RAD001) and Exemestane in the Treatment of Postmenopausal Women with Estrogen Receptor Positive Her2 Negative Locally Advanced or Metastatic Breast Cancer

Purpose

Aromatase inhibitors are drugs used in postmenopausal women to treat breast cancers that are fueled by estrogen. They interfere with the production of estrogen in the body. However, in some women, the breast cancer stops responding to these drugs. Exemestane is an example of an aromatase inhibitor.

In this study, researchers want to find the highest dose of an investigational drug called LEE011 that can be given safely with exemestane and with another drug, everolimus, in postmenopausal women with locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancers that continue to grow despite aromatase inhibitor therapy.

Everolimus is a drug used in combination with exemestane. It works by blocking the activity of a molecule called mTOR, which helps cancer cells grow. LEE011 blocks a protein called CDK, which tells cancer cells to divide. Researchers hope LEE011 will slow the growth of cancer cells and lead to their death.

Patients in this study will receive LEE011 with exemestane and everolimus, or LEE011 with exemestane alone. All three drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients may not have received more than one prior regimen of chemotherapy for advanced breast cancer

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Shanu Modi at 646-888-5243.